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Open, Classified

Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

FDA Recall Z-2192-2025 · Posted 2025-07-29

Recalling FirmPhasor Health, LLC
Recall StatusOpen, Classified
Product CodeHBE
Date Initiated2025-03-21
Product Quantity1,064

Reason for Recall

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

Firm Action

Starting on 3/21/2025, device correction and removal began and a correction and removal notice was emailed. Customers were asked to do the following: 1) Review inventory (without opening the sterile transparent barrier) to determine if any of the affected lots remain in inventory. If yes, remove those lots from inventory. Do not use drills with reverse battery orientation. 2) If unable to review inventory soon, the Company will come to your site within 30 business days of this letter and inspect your inventory (within 20 minutes total) and replace any defective drills with new verified stock (same catalog number). 3) Contact firm at [email protected] to report results of inventory inspection and to facilitate device return. 4) Complete and return the acknowledgement and receipt form via email to [email protected] Please contact Firm at [email protected] or (832) 982-1234 for more information or questions

Root Cause

Process change control

Distribution Pattern

US: PA, IN, AZ, MO, LA, FL, TX, MA, OH, TN, MI, WV, VA, CA, DE, NH, GA, SC, GU, NY, NJ, MN, WI, NE, WA, IL, AR, PR, VT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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